The ABCs of Implementing Risk-Based Thinking

Whether your new product is a hybrid vehicle, ketchup bottle or a molecular assay to detect a disease, the use of risk-based thinking is critical to designing products and processes that deliver the maximum benefits at the lowest risk. Every company uses risk-based thinking, and this session provides insights on how to implement the practice effectively and efficiently. In particular, the presentation provides an overview of standards ISO 9001:2015, ISO 13485:2016 and IATF 16949:2016 and demonstrates a method to apply risk-based thinking from definition of customer requirements through delivery, installation and usage of the product, using an example that can be applied as a template for other organizations.